01-4619. Proposed Collection; Comment Request; Study of Physician Researchers Concerning Research and Clinical Care Activities

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Department of Clinical Bioethics, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection: Title: Study of Physician Researchers Concerning Research and Clinical Care Activities. Type of Information Collection Request: New. Need and Use of Information Collection: In order to understand the sometimes-conflicting obligations of physicians involved in clinical research, it is important to study their own understanding of their work and responsibilities as researchers and as clinicians treating patients. This study aims to gather this information through interviews with physicians involved in clinical research and other experts knowledgeable about their work. In particular, the study aims to identify and examine what physicians experience as the nature of the conflict between their roles as caregiver and researcher, physicians' most recent case of conflict between treatment and research, pressures on physicians involved in research and how they address or resolve them, conflict between caring for patients and gaining generalizable knowledge, and the influence of the work and institutional setting on physicians undertaking medical research. Frequency of Response: Once for the survey administration and for individuals interviewed and on occasion thereafter. Affected Public: Individuals. Type of Respondents: Physicians involved in clinical research and other interviewees knowledgeable about their practices. Annual Reporting Burden: The annual reporting burden follows in the table below. Annualized Cost to Respondents: The annualized cost to respondents is estimated at: $11,000. Capital Costs: There are no capital costs to report. Operating or Maintenance Costs: There are no operating or maintenance costs to report.

Respondent and Burden Estimate Information

Type of respondents	Estimated number of respondents	Estimated number of response per respondent	Average burden hours per response	Estimated total annual burden hours requested
Physician Researchers	250	1	.5	125
Physician Researchers	80	1	1	80
Non-Physician-Researcher Interviewees	20	1	1	20
Total				225

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Elaine Draper, Ph.D., J.D., Department of Clinical Bioethics, NIH, Building 10, Room 1C118F, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free number [phone] or E-mail your request, including your address to: [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received on or before April 27, 2001.

Dated: February 14, 2001.

David K. Henderson,

Deputy Director for Clinical Care.